# K230185: ANT-X System

- Pathway: 510(k) (Abbreviated)
- Applicant: Ndr Medical Technology Pte., Ltd.
- Decided: Jun 1, 2023 after 129 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K013841 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170800: NuVasive LessRay with Enhanced Tracking, Nu Vasive, Incorporated (2017) Summary page 4.

## Indications for use
The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.

Source page: https://510kreport.com/device/K230185
Methodology: https://510kreport.com/methodology